Spain Authorized 216 Rare Disease Clinical Trials in 2025

Why this is here: The pharmaceutical industry initiated 212 of the 216 rare disease clinical trials approved in Spain during 2025, an 8% increase from the previous year.

In Spain, authorities authorized 216 clinical trials focused on rare diseases in 2025. The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories reported a 4% increase from 2024. These trials represent 22% of the total 962 clinical trials authorized nationally that year.

Catalonia, Madrid, and Andalusia spearheaded the research activity. Together, these regions hosted more than half of all trials across different health areas. Catalonia led with participation in 171 studies, followed by Madrid with 151, and Andalusia with 100.

However, when adjusting for population size, regions like Navarre, Galicia, and the Basque Country showed higher rates of trials per million residents. The pharmaceutical industry promoted 98% of these rare disease trials, totaling 212 studies.

Oncology remained the primary therapeutic area, though its share decreased slightly, while trials targeting the immune and nervous systems increased. The report does not detail long-term outcomes or patient impact.